Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
4000 participants
INTERVENTIONAL
2000-11-30
2008-10-31
Brief Summary
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Detailed Description
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HYVET is a randomised, double-blind, placebo-controlled trial in hypertensive subjects aged 80 or older. Active treatment consists of indapamide 1.5mg SR with the addition of perindopril 2mg - 4mg to reach a target blood pressure (BP) of \<150/80 mmHg. Entry criteria include a systolic blood pressure of 160-199 mmHg. Patients with isolated systolic hypertension (ISH) have been recruited since August 2003.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Interventions
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Indapamide SR 1.5mg; Perindopril 2-4mg
Eligibility Criteria
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Inclusion Criteria
* Sitting systolic BP 160-199 mmHg AND sitting diastolic BP \< 110 mmHg
Exclusion Criteria
* Overt clinical congestive heart failure requiring treatment with a diuretic or angiotensin converting enzyme inhibitor. Subjects allowed if treated with digoxin only.
* Renal failure (serum creatinine of more than 150 µmol/l).
* Previous documented cerebral or subarachnoid haemorrhage in the last 6 months. (Ischaemic cerebral and cardiac events do not exclude, although the patient must be neurologically and cardiologically stable.)
* Condition expected to severely limit survival, e.g. terminal illness.
* Known secondary hypertension (e.g. renal artery stenosis, chronic renal insufficiency, and endocrine cause).
* Gout.
* Clinical diagnosis of dementia.
* Resident in a nursing home, i.e. where the dependency and care requirements of the patients are such that they require the regular input of qualified nurses and therefore the majority of staff in the home are nurses (other forms of residential care are acceptable).
* Unable to stand up or walk
* Participation in a drug trial within the past month preceding selection.
* Alcohol or drug abuse.
* Less than 2 months placebo run-in.
* Contraindications to use of trial drugs
80 Years
ALL
No
Sponsors
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British Heart Foundation
OTHER
Institut de Recherches Internationales Servier
OTHER
Imperial College London
OTHER
Principal Investigators
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Christopher J Bulpitt, MD, FRCP
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
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Department of Internal Medicine, Clinic of Rheumatology
Plovdiv, , Bulgaria
University Hospital St. Anna
Sofia, , Bulgaria
Dept of Hypertension Fu Wai Hospital
Beijing, , China
Kontinkangas Hospital Research
Oulu, , Finland
UMF Cluj, Clinica Medicala III
Cluj-Napoca, , Romania
State Scientific Research Institute of Internal Medicine, Russian Academy of Medical Sciences Siberian Department
Novosibirsk, , Russia
Imperial College London
London, , United Kingdom
Countries
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References
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Bulpitt C, Fletcher A, Beckett N, Coope J, Gil-Extremera B, Forette F, Nachev C, Potter J, Sever P, Staessen J, Swift C, Tuomilehto J. Hypertension in the Very Elderly Trial (HYVET): protocol for the main trial. Drugs Aging. 2001;18(3):151-64. doi: 10.2165/00002512-200118030-00001.
Bulpitt CJ, Peters R, Staessen JA, Thijs L, De Vernejoul MC, Fletcher AE, Beckett NS. Fracture risk and the use of a diuretic (indapamide SR) +/- perindopril: a substudy of the Hypertension in the Very Elderly Trial (HYVET). Trials. 2006 Dec 19;7:33. doi: 10.1186/1745-6215-7-33.
Peters R, Beckett N, Nunes M, Fletcher A, Forette F, Bulpitt C. A substudy protocol of the hypertension in the Very Elderly Trial assessing cognitive decline and dementia incidence (HYVET-COG) : An ongoing randomised, double-blind, placebo-controlled trial. Drugs Aging. 2006;23(1):83-92. doi: 10.2165/00002512-200623010-00008.
Pinto E, Bulpitt C, Beckett N, Peters R, Staessen JA, Rajkumar C. Rationale and methodology of monitoring ambulatory blood pressure and arterial compliance in the Hypertension in the Very Elderly Trial. Blood Press Monit. 2006 Feb;11(1):3-8. doi: 10.1097/01.mbp.0000184965.30220.10.
Cunningham EL, Todd SA, Passmore P, Bullock R, McGuinness B. Pharmacological treatment of hypertension in people without prior cerebrovascular disease for the prevention of cognitive impairment and dementia. Cochrane Database Syst Rev. 2021 May 24;5(5):CD004034. doi: 10.1002/14651858.CD004034.pub4.
Antikainen RL, Peters R, Beckett NS, Fagard RH, Wang JG, Rajkumar C, Bulpitt CJ. Left ventricular hypertrophy is a predictor of cardiovascular events in elderly hypertensive patients: Hypertension in the Very Elderly Trial. J Hypertens. 2016 Nov;34(11):2280-6. doi: 10.1097/HJH.0000000000001073.
Warwick J, Falaschetti E, Rockwood K, Mitnitski A, Thijs L, Beckett N, Bulpitt C, Peters R. No evidence that frailty modifies the positive impact of antihypertensive treatment in very elderly people: an investigation of the impact of frailty upon treatment effect in the HYpertension in the Very Elderly Trial (HYVET) study, a double-blind, placebo-controlled study of antihypertensives in people with hypertension aged 80 and over. BMC Med. 2015 Apr 9;13:78. doi: 10.1186/s12916-015-0328-1.
Peters R, Beckett N, Pereira L, Poulter R, Pinto E, Ma S, Dumitrascu D, Barrowdale D, Butler M, Fletcher A, Bulpitt C. The clock drawing test, mortality, incident cardiovascular events and dementia. Int J Geriatr Psychiatry. 2015 Apr;30(4):416-21. doi: 10.1002/gps.4153. Epub 2014 Jun 12.
Antikainen RL, Beckett N, Peters R, Fagard R, Rajkumar C, Wang J, Stoyanovsky V, Barrowdale D, Bulpitt CJ; HYVET Study Group. Prevalence and covariates of electrocardiographic left ventricular hypertrophy in the Hypertension in the Very Elderly Trial. J Hypertens. 2013 Jun;31(6):1224-32. doi: 10.1097/HJH.0b013e32836040a4.
Peters R, Beckett N, Poulter R, Burch L, Narkiewicz K, Fagard R, Nitsch D, Wang N, Li M, Fletcher A, Bulpitt C. Kidney function in the very elderly with hypertension: data from the hypertension in the very elderly (HYVET) trial. Age Ageing. 2013 Mar;42(2):253-8. doi: 10.1093/ageing/afs109. Epub 2012 Aug 21.
Beckett N, Peters R, Tuomilehto J, Swift C, Sever P, Potter J, McCormack T, Forette F, Gil-Extremera B, Dumitrascu D, Staessen JA, Thijs L, Fletcher A, Bulpitt C; HYVET Study Group. Immediate and late benefits of treating very elderly people with hypertension: results from active treatment extension to Hypertension in the Very Elderly randomised controlled trial. BMJ. 2011 Jan 4;344:d7541. doi: 10.1136/bmj.d7541.
Peters R, Beckett N, Burch L, de Vernejoul MC, Liu L, Duggan J, Swift C, Gil-Extremera B, Fletcher A, Bulpitt C. The effect of treatment based on a diuretic (indapamide) +/- ACE inhibitor (perindopril) on fractures in the Hypertension in the Very Elderly Trial (HYVET). Age Ageing. 2010 Sep;39(5):609-16. doi: 10.1093/ageing/afq071. Epub 2010 Jun 23.
Peters R, Pinto E, Beckett N, Swift C, Potter J, McCormack T, Nunes M, Grimley-Evans J, Fletcher A, Bulpitt C. Association of depression with subsequent mortality, cardiovascular morbidity and incident dementia in people aged 80 and over and suffering from hypertension. Data from the Hypertension in the Very Elderly Trial (HYVET). Age Ageing. 2010 Jul;39(4):439-45. doi: 10.1093/ageing/afq042. Epub 2010 May 23.
Peters R, Beckett N, Forette F, Tuomilehto J, Ritchie C, Walton I, Waldman A, Clarke R, Poulter R, Fletcher A, Bulpitt C. Vascular risk factors and cognitive function among 3763 participants in the Hypertension in the Very Elderly Trial (HYVET): a cross-sectional analysis. Int Psychogeriatr. 2009 Apr;21(2):359-68. doi: 10.1017/S1041610208008302. Epub 2009 Feb 27.
Peters R, Beckett N, Forette F, Tuomilehto J, Clarke R, Ritchie C, Waldman A, Walton I, Poulter R, Ma S, Comsa M, Burch L, Fletcher A, Bulpitt C; HYVET investigators. Incident dementia and blood pressure lowering in the Hypertension in the Very Elderly Trial cognitive function assessment (HYVET-COG): a double-blind, placebo controlled trial. Lancet Neurol. 2008 Aug;7(8):683-9. doi: 10.1016/S1474-4422(08)70143-1. Epub 2008 Jul 7.
Beckett NS, Peters R, Fletcher AE, Staessen JA, Liu L, Dumitrascu D, Stoyanovsky V, Antikainen RL, Nikitin Y, Anderson C, Belhani A, Forette F, Rajkumar C, Thijs L, Banya W, Bulpitt CJ; HYVET Study Group. Treatment of hypertension in patients 80 years of age or older. N Engl J Med. 2008 May 1;358(18):1887-98. doi: 10.1056/NEJMoa0801369. Epub 2008 Mar 31.
Other Identifiers
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RG/97010
Identifier Type: -
Identifier Source: org_study_id